GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV
Information provided by (Responsible Party)
First received: March 5, 2018
Last updated: December 18, 2019
Last Verified: December 2019
History of Changes
The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and/or limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via https://us.viivhealthcare.com/media/124424/viivs-external-policy-on-cup_final-version_23feb20 17.pdf.
Infection, Human Immunodeficiency Virus
Drug : cabotegravir, CAB
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV|
Further study details as provided by ViiV Healthcare:
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
- HIV-infected patients will be eligible for treatment if ALL the following apply:
- Male or female patients aged ≥ 18 yrs
NOTE: all female patients of reproductive potential should use every precaution to prevent pregnancy including either complete abstinence from intercourse from 2 weeks prior to administration of CAB, throughout receipt of CAB and for at least 52 weeks after discontinuation of CAB LA; or use of one of the following methods of highly reliable contraception:
- Contraceptive subdermal implant
- Intrauterine device or intrauterine system
- Combined estrogen and progestogen oral contraceptive
- Injectable progestogen
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- Male partner sterilisation with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's: review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.
- Inability to construct a viable antiviral treatment regimen with commercially available medications;
- Demonstrated need for a long acting, injectable antiretroviral including, but not limited to malabsorption or inability to achieve adequate drug levels via oral route. NOTE: Poor/incomplete adherence to oral meds is not a sufficient rationale for inclusion.
- The patient/legal guardian or representative has given informed consent to treatment prior to administering CAB (in a manner consistent with all national requirements). The patient/legal guardian or representative has also given informed consent for the transmission of a copy of the anonymized adverse and serious adverse event (SAE) and pregnancy reports (in compliance with local regulatory authority requirements) to GSK and ViiV where allowable by local regulations, and to the country regulatory authority as required.
- Patients will not be eligible for treatment if ANY of the following apply:
- Patient has estimated creatinine clearance <50 mL/min via Cockcroft-Gault method;
- Females who are pregnant or women who are breastfeeding, or plan to become pregnant or breastfeed during treatment.
- Patients who have had known or suspected allergic reaction or hypersensitivity reactions to integrase inhibitors;
- Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN)
- ALT ≥ 3 times ULN and bilirubin ≥ 1.5 times ULN (with > 35% direct bilirubin)
- Evidence for moderate to severe hepatic impairment, grade 3-4 liver fibrosis, or cirrhosis
- Patients who are eligible for actively enrolling clinical trials involving CAB.
- Significant coagulopathy precluding chronic IM dosing
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03462810
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Sponsors and CollaboratorsViiV Healthcare
Study Director: GSK Clinical Trials ViiV Healthcare
Responsible Party: ViiV Healthcare ClinicalTrials.gov Identifier: NCT03462810 History of Changes Other Study ID Numbers: 205741 Study First Received: March 5, 2018 Last Updated: December 18, 2019
Keywords provided by ViiV Healthcare:cabotegravir, CAB
Individual Patient Compassionate Use
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.
These allowed methods of contraception are only effective when used consistently/correctly and in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.